Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 3:04 AM
Study NCT ID:
NCT05624333
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2022-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067269', 'term': 'Diet, Vegan'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Protein Synthesis (MPS)', 'timeFrame': '10 days', 'description': 'MPS, expressed as daily fractional synthesis rates (FSR, %/day), will be assessed using a deuterium oxide protocol. Daily FSR will be calculated using the 2\\^H-alanine enrichment in plasma and the mixed muscle-bound 2\\^H-alanine enrichment.'}], 'secondaryOutcomes': [{'measure': 'Appetite', 'timeFrame': 'Measured daily for 10 days during each diet', 'description': 'Appetite will be assessed using visual analogue scales (VAS; Min 0 mm - max 100 mm) before and after the warm meal. Five VAS-scales regarding hunger, fullness, satiation, desire to eat and prospective food consumption will be used to assess appetite.'}, {'measure': 'Change in fasting plasma glucose', 'timeFrame': 'Change after 10 days of following each diet', 'description': 'Fasting plasma glucose levels'}, {'measure': 'Change in fasting plasma insulin', 'timeFrame': 'Change after 10 days of following each diet', 'description': 'Fasting plasma insulin levels'}, {'measure': 'Change in fasting plasma lipid profile', 'timeFrame': 'Change after 10 days of following each diet', 'description': 'Triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein cholesterol, total cholesterol'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Change after 10 days of following each diet', 'description': 'Fasting systolic and diastolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '39732437', 'type': 'DERIVED', 'citation': 'Domic J, Pinckaers PJ, Grootswagers P, Siebelink E, Gerdessen JC, van Loon LJ, de Groot LC. A Well-Balanced Vegan Diet Does not Compromise Daily Mixed Muscle Protein Synthesis Rates when Compared with an Omnivorous Diet in Active Older Adults: A Randomized Controlled Cross-Over Trial. J Nutr. 2025 Apr;155(4):1141-1150. doi: 10.1016/j.tjnut.2024.12.019. Epub 2024 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'Consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. However, the consequences of such a transition on muscle mass still remains to be explored. This is of particular importance in the older population, where sarcopenia is highly prevalent. The aim of this randomized controlled cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet in 35 community-dwelling older adults.\n\nParticipants will follow a fully controlled vegan diet, directly followed by a fully controlled omnivorous diet for 10 days, or vice versa. Researchers will compare the effect of the vegan diet to the effect of the omnivorous diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65-79 years old;\n* Community-dwelling;\n* BMI 20-35 kg/m\\^2.\n\nExclusion Criteria:\n\n* Following a vegetarian or vegan diet during the six months prior to the study;\n* Following a diet that affects protein intake during the six months prior to the study;\n* Participating in a structured exercise training program in the past three months;\n* 5% or more body weight loss during three months before the start of the study;\n* Being diagnosed with one of the following: diabetes; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer; chronic obstructive lung disease (COPD);\n* Chronic use of medication that affects muscle function, e.g. corticosteroids, metformin, insulin;\n* The use of the following medicines: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole.\n* Allergic or intolerant to any product included in the diets;\n* Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D;\n* Not willing or afraid to give blood or undergo a muscle biopsy during the study;\n* Unwilling to eat a vegan and an omnivorous diet for ten days each;\n* Currently a research participant in another trial or participated in a clinical trial during three months before the start of the measurement period;\n* Not being able to understand Dutch;\n* Not having a general physician.'}, 'identificationModule': {'nctId': 'NCT05624333', 'acronym': 'VD2O', 'briefTitle': 'Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'Vegan Diets: the Short-term Effects on Daily Muscle Protein Synthesis Rates as Compared to Omnivorous Diets in Older Adults Assessed by D2O.', 'orgStudyIdInfo': {'id': 'NL82653.028.22'}, 'secondaryIdInfos': [{'id': 'NL9542', 'type': 'REGISTRY', 'domain': 'Netherlands Trial Register'}, {'id': 'NL76916.028.21', 'type': 'OTHER', 'domain': 'METC Brabant'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'VO group', 'description': 'Vegan diet followed by Omnivorous diet', 'interventionNames': ['Other: Vegan diet (intervention)', 'Other: Omnivorous diet (control)']}, {'type': 'OTHER', 'label': 'OV group', 'description': 'Omnivorous diet followed by Vegan diet', 'interventionNames': ['Other: Vegan diet (intervention)', 'Other: Omnivorous diet (control)']}], 'interventions': [{'name': 'Vegan diet (intervention)', 'type': 'OTHER', 'description': 'The intervention diet will be a fully controlled vegan diet that will be consumed for a duration of 10 days. No animal-based food products will be included in the diet.', 'armGroupLabels': ['OV group', 'VO group']}, {'name': 'Omnivorous diet (control)', 'type': 'OTHER', 'description': 'The control diet will be an a priori composed controlled omnivorous diet with a duration of 10 days. The omnivorous diet and the vegan diet will be isocaloric and isonitrogenous.', 'armGroupLabels': ['OV group', 'VO group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6708 WE', 'city': 'Wageningen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Wageningen University and Research', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Lisette de Groot', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rijksoverheid', 'class': 'UNKNOWN'}, {'name': 'Maastricht University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Ir. L.C.P.G.M. (Lisette) de Groot', 'investigatorFullName': 'Lisette de Groot', 'investigatorAffiliation': 'Wageningen University'}}}}